跳至主要内容
临床试验/NCT04060186
NCT04060186Unknown不适用

Balloninflation After Evacuation of Chronical Subdural Haematoma for Reduction of Hematoma Recurrrence: Randomized Controlled Study

Johann Wolfgang Goethe University Hospital2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
2
主要终点
Recurrence Rate

研究概览

简要总结

In this prospective, randomized, multicenter trial shall patients with chronic subdural hematoma (cSDH) recruited, who were surgically treated. Initially, we would divide the patients randomized into two groups: Patients with supervised blow-maneuver and without. After surgical treatment of cSDH with insertion of a subdural drain, one group would perform a supervised blow maneuver ("Valsalva maneuver") every hour for five minutes from 10:00 to 20:00. In the other group, the standard care would be performed. The subdural drain would be explanted 2days after operation and a postoperative CT scan would routinely be performed. After hospital discharge, the patient would be rechecked in an ambulant setting and would receive CT scan as clinical standard. Recurrence of hematoma is defined as recurrent hematoma which should be reoperated. After 3 and 6 months we would evaluate the outcome of patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age over 18 years
  • surgically treated cSDH
  • patients with an operatively implanted subdural drainage

排除标准

  • age under 18 years
  • Admission in critical clinical state, e.g. already to light unresponsive pupils for about 2 hours
  • conservative treatment of cSDH
  • patients without an operatively implanted subdural drainage
  • patient cannot be consented
  • participation in other clinical trials

结局指标

主要结局

Recurrence Rate

时间窗: 3 Months

Reoperation of chronic subdural hematoma

次要结局

  • Neurological Functional Outcome(6 Months)

研究者

发起方
Johann Wolfgang Goethe University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marina Heibel

Study Nurse

Johann Wolfgang Goethe University Hospital

研究点 (2)

Loading locations...

相似试验